Z-0366-2017 Class II Terminated
FDA device recall Z-0366-2017 was initiated by Covidien LLC on Sep 29, 2016 and is designated Class II. Reason for recall: Added Instructions for Use: After application, inspect the Light Glove for barrier integrity The recall status is terminated (terminated Apr 5, 2019). Affected quantity: 4950 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2016
- Initiation Date
- Sep 29, 2016
- Termination Date
- Apr 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4950 units
Product Description
Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
Reason for Recall
Added Instructions for Use: After application, inspect the Light Glove for barrier integrity
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign: Canada: Andorra Austria Belgium Czech Republic Denmark Finland France Germany Greece Ireland Israel Italy Latvia Luxembourg Monaco Netherlands Norway Poland Portugal Russian Federation Saudi Arabia Slovenia South Africa Spain Sweden Switzerland United Arab Emirates United Kingdom
Code Information
All lot codes in the following: Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK 400383007 MAJOR BASIN PACK 618275004 BASIN PACK
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0366-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026